ANTI-ITCH CREAM- diphenhydramine hcl / zinc acetate cream 
Front Pharmaceutical PLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Fourstar Group Anti-Itch Cream

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc Acetate 0.1%

Purpose

Topical Analgesic

Skin Protectant

Use

for temporary relief from pain and itching associated with insect bites, sunburn, and minor skin irritations. Dries the oozing and weeping of poison:

For external use only

Do not use

When using this product

Ask a doctor before use

Stop use and ask a doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polyoxyethylene lauryl ether, propylene glycol, propylparaben, purified water, stearic acid, stearyl alcohol

Questions

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Other information

Extra Strength

Anti-Itch Cream

Topical Analgesic and Skin Protectant Cream

Net Wt 1 oz (28 g)

Front Panel

ANTI-ITCH CREAM 
diphenhydramine hcl / zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
LAURETH-15 (UNII: 002FR4N8OV)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69571-011-011 in 1 BOX09/25/2023
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/25/2023
Labeler - Front Pharmaceutical PLC (530897792)
Establishment
NameAddressID/FEIBusiness Operations
Front Pharmaceutical530897792manufacture(69571-011)

Revised: 9/2023
Document Id: 05d3f15b-bb35-191a-e063-6294a90a3b4a
Set id: 05d3f15b-bb34-191a-e063-6294a90a3b4a
Version: 1
Effective Time: 20230920
 
Front Pharmaceutical PLC